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Molecular assay for C. diff, 8/17

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August 2017—Quidel received 510(k) clearance to market its Solana C. difficile Assay for the direct, qualitative detection of Clostridium difficile DNA in unformed stool specimens of patients suspected of having Clostridium difficile infection.

The Solana C. difficile Assay is a molecular diagnostic test that generates results, without an upfront nucleic acid extraction step, in about 35 minutes.

The Solana molecular platform uses helicase-dependent amplification technology combined with fluorescence detection and can process up to 12 different assays or patient samples in each batched run.

Quidel, 800-874-1517

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